Dinical study report

Information amendments are used to inform the FDA of new pharmacology or toxicology data, final non-dinical study reports, new chemistry-manufacturing-control information, or notice of the discontinuation of a clinical study. 

This module should contain data from all of the non-dinical studies conducted to investigate the pharmacological and toxicological properties of the dmg substance/ product. The standard headings used to present this information are shown in Figure 6.4. Study reports should be presented in the following order according to species and route of administration ... 

N,N-Dimethylttyptamine (DMT) is a representative of the tryptamin i.e. indole-3-alkylamine, family. Note the stmc-tural similarity to serotonin which is 5-hydroxyttyptamine (Fig. 18.33). DMT is parenterally, but not orally, active at around 60-100 mg of the free base since rapid deamination by monoamine oxidase oteurs following oral administration. Pharmacological effects are therefore induced by inhalation of the free base vapour or by injection of a water-soluble salt. The fumarate salt has been used in a number of human dinical studies and it was reported that the psychoactive effects are relativdy short-lived, with durations less than 1 horn. Smoking of the free base leads to very intense but short-lived effects for around 5-15 minutes. A number of N-mono and dimethylated tryptamines are also present in several human tissues. Thdr exact function has been debated for several decades but so far no definite condusion has been reached. 

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